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Amgen Manufacturing Limited LLC — FDA Facility Profile

FEI 1000110364

Amgen Manufacturing Limited LLC is an FDA-registered facility (FEI 1000110364) located in Juncos, PR, US. Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK. RegDataLab tracks 10 or more FDA inspections at this facility.

Facility Details

Location
Juncos, PR (US)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK
Source
decrs

Recent inspections

  • 1294400 (VAI Mon Apr 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1209484 (VAI Wed Jul 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1085900 (VAI Thu Apr 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061201 (VAI Mon Aug 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1016325 (VAI Wed May 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 913643 (VAI Wed Feb 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 912248 (VAI Fri Jan 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 844890 (VAI Thu Aug 15 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 824936 (VAI Fri Mar 29 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 756906 (VAI Fri Jan 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 799-9691005-7/10003/1 (Tue Dec 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • NUV-3849644-7/10002/1 (Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources